Microsoft Word - PressRelease：PROEMEND additional indication application for pediatric patients 20150527.docx


May 27, 2015

ONO Submits Additional Indication Application for "PROEMEND® for Intravenous Infusion 150mg" for the Treatment of Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients Aged 6 Months and Older

ONO PHARMACEUTICAL CO., LTD. (Osaka, Japan; President, Representative Director and CEO, Gyo Sagara; "ONO") announced today that it has submitted an additional indication application of antiemetic drug PROEMEND® for Intravenous infusion 150mg (generic name: Fosaprepitant Meglumine; "PROEMEND") , for the treatment of chemotherapy-induced nausea and vomiting in pediatric patients aged 6 month and older.
The drug has been exclusively developed by ONO in Japan, under the license agreement signed by ONO and Merck Sharp & Dohme Corp. (MSD, known as Merck inside the United States and Canada) in November 2004 and launched in December 2011.
ONO launched EMEND® Capsules (generic name; Aprepitant; "EMEND"), an oral drug for the treatment of chemotherapy-induced nausea and vomiting, in December 2009. And then ONO received an approval of additional indication of EMEND for pediatric patients aged 12 years and older in June 2012 to respond the requests from medical sites.
However, EMEND is not indicated for pediatric patients aged under 12 years , and it is administered in the form of capsule which is hard to take for pediatric patients. For that reason, ONO had been received strong needs of development of PROEMEND for pediatric patients by medical sites.
ONO is committed to receiving an early approval of additional indication of PROEMEND for pediatric patients aged 6 months and older, to meet the needs of many patients suffering from chemotherapy-induced nausea and vomiting.

Contact

ONO PHARMACEUTICAL CO., LTD. Corporate Communications public_relations@ono.co.jp

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